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AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) has determined that OPANA ER (oxymorphone hydrochloride (HCl)) extended-release tablets, 7.5 milligrams (mg) and 15 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs for oxymorphone HCl extended-release tablets, 7.5 mg and 15 mg, if all other legal and regulatory requirements are met.

SUPPLEMENTARY INFORMATION:

In 1984, Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments), which authorized the approval of duplicate versions of drug products under an ANDA procedure. ANDA applicants must, with certain exceptions, show that the drug for which they are seeking approval contains the same active ingredient in the same strength and dosage form as the “listed drug,” which is a version of the drug that was previously approved. ANDA applicants do not have to repeat the extensive clinical testing otherwise necessary to gain approval of a new drug application (NDA). The only clinical data required in an ANDA are data to show that the drug that is the subject of the ANDA is bioequivalent to the listed drug.

The 1984 amendments include what is now section 505(j)(7) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(j)(7)), which requires FDA to publish a list of all approved drugs. FDA publishes this list as part of the “Approved Drug Products With Therapeutic Equivalence Evaluations,” which is known generally as the “Orange Book.” Under FDA regulations, drugs are removed from the list if the Agency withdraws or suspends approval of the drug's NDA or ANDA for reasons of safety or effectiveness or if FDA determines that the listed drug was withdrawn from sale for reasons of safety or effectiveness (21 CFR 314.162).

Under § 314.161(a) (21 CFR 314.161(a)), the Agency must determine whether a listed drug was withdrawn from sale for reasons of safety or effectiveness: (1) Before an ANDA that refers to that listed drug may be approved; (2) whenever a listed drug is voluntarily withdrawn from sale and ANDAs that refer to the listed drug have been approved; and (3) when a person petitions for such a determination under §§ 10.25(a) and 10.30 (21 CFR 10.25(a) and 10.30). Section 314.161(d) provides that if FDA determines that a listed drug was withdrawn from sale for reasons of safety or effectiveness, the Agency will initiate proceedings that could result in the withdrawal of approval of the ANDAs that refer to the listed drug.

OPANA ER (oxymorphone HCl) extended-release tablets, 7.5 mg and 15 mg, are the subject of NDA 021610, held by Endo Pharmaceuticals, and initially approved on June 22, 2006. OPANA ER is indicated for the relief of moderate to severe pain in patients requiring continuous, around-the-clock opioid treatment for an extended period of time.

OPANA ER (oxymorphone HCl) extended-release tablets, 7.5 mg and 15 mg, are currently listed in the “Discontinued Drug Product List” section of the Orange Book. There are approved ANDAs for oxymorphone HCl extended-release tablets, 7.5 mg and 15 mg; these ANDAs are listed in the Orange Book. The other strengths of OPANA ER—both lower and higher strengths than 7.5 mg and 15 mg—continue to be marketed.

After considering the citizen petitions and reviewing Agency records and based on the information we have at this time, FDA has determined under § 314.161 that OPANA ER (oxymorphone HCl) extended-release tablets, 7.5 mg and 15 mg, were not withdrawn for reasons of safety or effectiveness. The petitioners have identified no data or other information suggesting that OPANA ER (oxymorphone HCl) extended-release tablets, 7.5 mg and 15 mg, were withdrawn for reasons of safety or effectiveness. We have carefully reviewed our files for records concerning the withdrawal of OPANA ER (oxymorphone HCl) extended-release tablets, 7.5 mg and 15 mg, from sale. We have also independently evaluated relevant literature and data for possible postmarketing adverse events. In addition, we have considered that the 7.5 mg and 15 mg strengths are bracketed by other strengths that are still being marketed. We have found no information that would indicate that OPANA ER (oxymorphone HCl) extended-release tablets, 7.5 mg and 15 mg, were withdrawn from sale for reasons of safety or effectiveness.

Accordingly, the Agency will continue to list OPANA ER (oxymorphone HCl) extended-release tablets, 7.5 mg and 15 mg, in the “Discontinued Drug Product List” section of the Orange Book. The “Discontinued Drug Product List” delineates, among other items, drug products that have been discontinued from marketing for reasons other than safety or effectiveness. FDA will not begin procedures to withdraw approval of ANDAs that refer to these drug products. Additional ANDAs that refer to OPANA ER (oxymorphone HCl) extended-release tablets, 7.5 mg and 15 mg, may be approved by the Agency as long as they meet all other legal and regulatory requirements for the approval of ANDAs. If FDA determines that labeling for this drug product should be revised to meet current standards, the Agency will advise ANDA applicants to submit such labeling.